NCT07456124

Brief Summary

This prospective observational study investigates weight loss and metabolic changes in adults with obesity undergoing standard clinical diet-induced lifestyle treatment and counseling. Participants follow a very-low-calorie diet followed by a conventional weight loss diet in addition to lifestyle counseling and are followed for 12 months. The study examines weight loss as the primary outcome and characterizes changes in body composition, fat distribution, glucose metabolism, inflammation, and adipose tissue biology as secondary outcomes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2016

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

January 21, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

Weight lossobesityadipose tissueinflammationmitochondriametabolismconservative treatment of obesitylifestyle intervention of obesity

Outcome Measures

Primary Outcomes (1)

  • Percent Total Body Weight Loss (%TWL)

    Percentage change in body weight from baseline, calculated as 100 × (baseline weight - follow-up weight) / baseline weight

    Baseline to 6 months

Secondary Outcomes (14)

  • Change in Body Weight (kg)

    Baseline to 6 and to 12 months

  • Change in Total Body Fat Mass (kg)

    Baseline to 6 months and to 12 months

  • Change in Body Fat percentage (%)

    Baseline to 6 and to 12 months

  • Change in Plasma Glycated Hemoglobin (HbA1c)

    Baseline to 6 months and to 12 months

  • Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)

    Baseline to 6 and to 12 months

  • +9 more secondary outcomes

Study Arms (1)

Diet-Induced Weight Loss Cohort

Adults with obesity undergoing standard clinical diet treatment including a very-low-calorie diet followed by transition to a conventional weight loss diet and lifestyle counseling

Behavioral: Diet-Induced Weight Loss Program

Interventions

Standard clinical obesity treatment consisting of a very-low-calorie diet for approximately 10 weeks followed by transition to a conventional weight loss diet with multidisciplinary clinical follow-up.

Diet-Induced Weight Loss Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seeking treatment for obesity at Helsinki University Central Hospital and affiliated outpatient obesity clinics.

You may qualify if:

  • Age ≥18 years
  • BMI ≥28 kg/m²
  • Seeking treatment for obesity at Helsinki University Central Hospital or affiliated units

You may not qualify if:

  • Pregnancy or lactation
  • Current smoking
  • Anemia (Hb \<130 g/L in men; \<120 g/L in women)
  • Severe comorbid disease or condition judged by investigator to compromise safety
  • Contraindications to MRI (e.g., metal implants, claustrophobia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, serum, subcutaneous adipose tissue in four depots

MeSH Terms

Conditions

ObesityOverweightWeight LossInflammation

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Docent in Experimental Internal Medicine

Study Record Dates

First Submitted

January 21, 2026

First Posted

March 6, 2026

Study Start

August 19, 2014

Primary Completion

August 17, 2016

Study Completion

August 17, 2016

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data are not publicly shared due to data protection regulations; anonymized data may be available upon reasonable request after study completion.